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# FDA Denies Novo Nordisk Petion on Liraglutide ANDAs
- URL: https://www.fdaweb.com/fda-denies-novo-nordisk-petion-on-liraglutide-andas/
- Published: 2018-01-08T12:00:00.000Z
- Updated: 2026-09-14T23:11:49.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5140439

FDA has denied a 10/2017 Novo Nordisk petition asking it not to approve any ANDA referencing any of the company’s liraglutide-containing drugs as the reference-listed drug. Novo Nordisk identified the drugs in question as Victoza (liraglutide) injection, Saxenda (liraglutide) injection, or Xultophy (insulin degludec and liraglutide injection). The [petition](https://www.regulations.gov/contentStreamer?documentId=FDA-2017-P-6029-0001&attachmentNumber=1&contentType=pdf&ref=fdaweb.com) also asked that the agency:

- not approve any 505(b)(2) NDA that references any of the company’s liraglutide-containing drugs unless and until the sponsor provides data from clinical comparative studies sufficient to establish that it is appropriate for FDA to rely on the agency’s findings of safety and effectiveness for the Novo Nordisk drug;
- issue guidance with “suitably stringent standards, as detailed in this petition, for assessing whether a follow-on liraglutide product, whether synthetic or recombinant-derived, is sufficiently similar to Novo Nordisk’s liraglutide to justify reliance on FDA’s prior findings of safety and effectiveness;” and
- consider issues raised in the petition in developing guidance for and reviewing applications for follow-on versions of other polypeptide and complex polypeptide drugs.

In its [denial action](https://t.co/8y45abIzhG?ref=fdaweb.com), FDA noted that a draft guidance has not been finalized on ANDA recoemmendations for such products. It urged the company to participate in the guidance’s development by submitting comments for review. It also declined to address the petition’s requests because “to do so would be premature.”